(60 days)
The FOSFATEMIA UV AA test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
End point method. Inorganic phosphate reacts with molybdate in the presence of acid to form a phosphomolybdate complex that is measured photometrically at 340 nm.
This document describes the Wiener lab. FOSFATEMIA UV AA Test System, an in-vitro diagnostic device for measuring inorganic phosphorus. The device's acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Wiener lab. FOSFATEMIA UV AA Test System are primarily based on its equivalence and performance characteristics compared to the predicate device, the ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system.
| Acceptance Criteria (based on Predicate Device) | Wiener lab. FOSFATEMIA UV AA Reported Performance |
|---|---|
| Intended Use: Measurement of inorganic phosphorus. | Same: Intended to measure inorganic phosphorus in serum, plasma and urine. Used in diagnosis and treatment of various disorders (parathyroid gland and kidney diseases, vitamin D imbalance). |
| Test Principle: End point method. Inorganic phosphate reacts with molybdate in the presence of sulfuric acid to form a phosphomolybdate complex measured photometrically at 340 nm. | Same: End point method. Inorganic phosphate reacts with molybdate in the presence of acid to form a phosphomolybdate complex measured photometrically at 340 nm. |
| Essential Components: Ammonium molybdate - Sulfuric acid. | Similar: R: Sulfuric acid and Ammonium molybdate. |
| Reagents: R1: Sulfuric acid and detergent. R2: Sulfuric acid, Ammonium molybdate and Sodium chloride. | R: Sulfuric acid and Ammonium molybdate. (Slight difference in multi-reagent vs. single reagent, but essential components are same) |
| Instability or Deterioration of Reagents: Not specified for predicate. | Absorbance of Reagent > 0.500 (This is a self-defined acceptance criterion for reagent stability). |
| Working Temperature Range: 25 – 37°C. | Same (implied, as no difference is stated, indicating equivalence). |
| Stability of Final Color: Not specified for predicate. | 20 minutes (This is a self-defined acceptance criterion for final color stability). |
| Wavelength of Reading: 340 nm. | Same: 340 nm. |
| Calibration: Single point. | Same: Single point. |
| Linearity: 20 mg/dl. | 16 mg/dl (This is a difference from the predicate, indicating it did not meet the predicate's linearity, but it is reported as its own performance characteristic. The document later concludes "substantial equivalency" despite this difference). |
| Minimum Detection Limit: Not specified for predicate. | 0.11 mg/dl (This is a self-defined performance characteristic). |
2. Sample Sizes Used for Test Set and Data Provenance
The provided document describes the device in terms of its characteristics and comparison to a predicate device for 510(k) submission. It does not present data from a clinical test set with specific sample sizes for patients or samples used to validate its performance. The information provided is about the device's technical specifications and a general claim of substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of Experts
This document does not mention the use of experts to establish ground truth for a test set. This type of information would typically be found in detailed performance studies, which are not included here. The "ground truth" for the comparison is the specifications of the predicate device.
4. Adjudication Method for the Test Set
As no specific clinical performance study or test set evaluation is detailed, no adjudication method is mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No MRMC comparative effectiveness study was performed or described in this document. This device is an in-vitro diagnostic test, not a medical imaging device or AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This device is an in-vitro diagnostic test, not an algorithm in the typical sense of AI/ML. Its performance is inherently standalone as it performs chemical reactions and provides a quantitative measurement. The information provided is essentially its standalone performance characteristics in comparison to a predicate device.
7. Type of Ground Truth Used
The "ground truth" implicitly used for the purpose of this 510(k) submission is the established performance characteristics and specifications of the legally marketed predicate device (ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system). The Wiener lab. device is asserting its equivalency to these established standards.
8. Sample Size for the Training Set
This document does not report on a training set sample size. Such a concept is typically relevant for machine learning algorithms, which is not the nature of this in-vitro diagnostic device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set described for this device, the method for establishing ground truth for a training set is not applicable and therefore not provided.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the text "Warner lab." around the top edge of the circle. Inside the circle are the words "ISO 9001" stacked on top of each other. Below that is the word "TUV" above the word "CERT", with two curved lines above and below the words "TUV" and "CERT".
NOV 1 6 2001
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside of a circle on the left, followed by the text "Wiener lab." in bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clinicos" in a smaller font.
WIENER LABORATORIOS S.A.I.C. - Rishamba 2944 - 2008 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet: http://www.wiener-lab.com.ar
Section 6 - Summary
510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92"
y "The assigned 510(k) number is: _గం)3095
According to the requirements of 21 CFR 862.1580, the following Introduction information provides sufficient details to understand the basis of a determination of substantial equivalence.
- Wiener Laboratorios S.A.I.C. 6-1 Submitter Riobamba 2944 Name, Address, 2000 - Rosario - Argentina Contact Tel: 54 341 4329191 Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: July 25, 2001
Proprietary name: Wiener lab. FOSFATEMIA UV AA 6-2 Device Name
Common name: Phosphorus (inorganic) test system
Classification name: Phosphomolybdate (Colorimetric), Inorganic Phosphorus, CEO, as per 21 CFR section 862.1580.
Device Class I
{1}------------------------------------------------
| 6-3 PredicateDevice | We claim substantial equivalence to the currently marketedROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP.INORGANIC PHOSPHORUS test system (Cat. Nº 836281) |
|---|---|
| 6-4 DeviceDescription | End point method. |
| Inorganic phosphate reacts with molybdate in the presence ofacid to form a phosphomolybdate complex that is measuredphotometrically at 340 nm. | |
| 6-5 Intended Use | The FOSFATEMIA UV AA test system is a device intended tomeasure inorganic phosphorus in serum, plasma and urine.Measurements of phosphorus (inorganic) are used in thediagnosis and treatment of various disorders, includingparathyroid gland and kidney diseases, and vitamin Dimbalance. |
| and Differences | 6-6 Equivalencies The Wiener lab. Inorganic Phosphorus test system issubstantially equivalent to other products in commercialdistribution intended for similar use. Most notably it is |
distribution intended for similar use. Most substantially equivalent to the currently marketed ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system.
The following table illustrates the similarities and differences between the Wiener lab. Inorganic Phosphorus test system and currently marketed ROCHE DIAGNOSTICS / the the BOEHRINGER PHOSPHORUS test system.
| ROCHE/BOEHRINGERTest System | WIENER LAB.Test System | |
|---|---|---|
| Intended Use | Method for measurement of inorganic phosphorus. | |
| ROCHE/BOEHRINGERTest System | WIENER LAB.Test System | |
| Test Principle | End point method.Inorganic phosphate reacts with molybdate in thepresence of sulfuric acid to form aphosphomolybdate complex that is measuredphotometrically at 340 nm. | |
| EssentialComponents | Ammonium molybdate - Sulfuric acid | |
| Reagents | R1: Sulfuric acid anddetergent.R2: Sulfuric acid, Ammoniummolybdate and Sodiumchloride. | R: Sulfuric acid andAmmonium molybdate. |
| Instability orDeteriorationof Reagents | Not specified | Absorbance ofReagent > 0.500. |
| WorkingTemperatureRange | 25 – 37°C | |
| Stability ofFinal Color | Not specified | 20 minutes |
| Wavelength ofReading. | 340 nm | |
| Calibration | Single point | |
| Linearity | 20 mg/dl | 16 mg/dl |
| MinimumDetectionLimit | Not specified | 0.11 mg/dl |
{2}------------------------------------------------
and the same of the state of the county of
{3}------------------------------------------------
6-7 Conclusion Above mentioned data show substantial equivalency to the predicate device.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 6 2001
Dr. Viviana Cétola QC/QA Manager Wiener Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe Argentina
Re: K013095
Trade/Device Name: Wiener Lab. Fosfatemia UV AA Test System Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) Test System Regulatory Class: I Product Code: CEO Dated: August 13, 2001 Received: September 17, 2001
Dear Dr. Cétola:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{5}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
CDRH ODE
NOV 1 6 2001
| 8geCC | C------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| ------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 510(k) Number (if known): | K013095 |
|---|---|
| Device Name: | Wiener lab. |
| Fosfatemia UV AA |
Indications For Use:
The "Wiener lab. Fosfatemia UV AA" test system is a quantitative in vitro diagnostic device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Labo | Aces |
| 510(k) Number | K013095 |
RECEIVED
FDA/CORE/ODE/C
SEP 17 12 20 PM 0.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBORD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use بـ
(Optional Format 1-2-96)
SK26
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.